510(k) K142553
K142553 is an FDA 510(k) premarket notification submitted by Unisis Corp. for the device "UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle". The FDA issued a decision of Substantially Equivalent on Jan 14, 2015. The device falls under product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)), a Class II device regulated under 21 CFR 868.5150. Unisis Corp. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 14, 2015
- Date Received
- Sep 10, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Needle, Conduction, Anesthetic (W/Wo Introducer)
- Device Class
- Class II
- Regulation Number
- 868.5150
- Review Panel
- AN
- Submission Type
- 510(k)